Status:
TERMINATED
Efficacy of the Erchonia Corporation THL™ for Providing Relief of Tinnitus Symptoms
Lead Sponsor:
Erchonia Corporation
Conditions:
Tinnitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this clinical study is to determine the effectiveness of the Erchonia® THL™, manufactured by Erchonia Corporation (the Company), for prescription home use in providing relief of tinnitu...
Detailed Description
Human Factors Validation Testing will initially be conducted to valuate a lay person's ability to understand and apply as applicable the information contained in the THL™ Use Device Proper Use Referen...
Eligibility Criteria
Inclusion
- Bilateral tinnitus
- Current diagnosis of subjective tinnitus
- No hearing loss or sensorineural hearing loss only
- 18 years of age or older
- Able to read and write English
- Constant tinnitus on-going over at least the past 6 months
- Willing to abstain from other tinnitus-related treatments, except existing hearing aid use, throughout the study duration.
- Tinnitus Functional Index (TFI) total score of 32 to 72 (Moderate to Big Problem)
- Degree of hearing loss is less than 60 dB (Moderate or less)
Exclusion
- Tympanosclerosis
- Meniere's disease
- Acoustic neuromas
- Current and consistent use of ototoxic medications
- Presbycusis
- Thyroid disease
- Skull fracture
- Traumatic brain injury (TBI)
- Depression
- Syphilis
- Retrocochlear tumors
- Conductive hearing loss
- Pregnant, think they might be pregnant, or breastfeeding.
- Open wounds (sores, cuts, ulcers, etc) around ears or neck
- Cancerous growths around ears or neck
- Difficulty with hand dexterity sufficient to impact the ability to administer treatments with the laser such as from severe arthritis in the hands, Multiple Sclerosis, -Cerebral Palsy, Parkinson's Disease, Huntington's Disease, etc.
Key Trial Info
Start Date :
May 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05374421
Start Date
May 10 2022
End Date
December 9 2022
Last Update
March 12 2024
Active Locations (1)
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1
Valley Audiology
Concord, California, United States, 94520